- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03929250
Recruitment Status Active, not recruiting
First Posted April 26, 2019
Last update posted September 17, 2020
This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders.
PRIMARY OBJECTIVES: 1. To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in the plasma and urine of cognitively healthy elders over 12 hours. 2. To determine the acute tolerability of a Centella asiatica product in cognitively healthy elders. OUTLINE: Participants will orally consume a single administration of a standardized Centella asiatica water extract product (CAP). Two doses (2g and 4g CAW) will be administered on separate occasions, at least two weeks apart. The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 12 hours after administration of each of the doses.
|Experimental: 2g CAW Dose
2g of Centella asiatica water extract in a standardized product.
Drug: 2g Centella asiatica water extract product
2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.
|Experimental: 4g CAW Dose
4g of Centella asiatica water extract in a standardized product.
Drug: 4g Centella asiatica water extract product
4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Age 65-85, male and female
2. Sufficient English language skills to complete all tests
3. Sufficient vision and hearing to complete all tests
4. No known allergies to Centella asiatica or CAP components
5. Willingness to discontinue all botanical dietary supplements for one week prior to and
during each study visit
6. Willingness to comply with a 48-hour low plant diet for each study visit
7. Absence of significant depression symptoms (Geriatric Depression Scale-15 score of
10. General health status that will not interfere with the ability to complete the study
1. Current smoking, alcohol or substance abuse according to DSM-V criteria
2. Women who are pregnant, planning to become pregnant or breastfeeding
3. Men who are actively trying to conceive a child or planning to within three months of
4. Severe aversion to venipuncture
5. Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract
6. Cancer within the last five years, with the exception of localized prostate cancer
(Gleason Grade 0.5 and MMSE
score <28 12. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
United States, Oregon
Oregon Health and Science University Department of Neurology
Oregon Health and Science University
Principal Investigator: Amala Soumyanath, PhD OHSU Department of Neurology